Patients and PPH Characteristics
From April 2014 to August 2018, 448 patients suffering from PPH were eligible for the study. After initial screening, 443 patients were randomized; 437 received the IMP and were retained in the ITT population of which 224 in the fibrinogen group and 213 in the placebo group (Figure 1).
Baseline characteristics did not differ between the two groups (Table 1 and Table S2). The predominant cause of haemorrhage was uterine atony (82%). The mean Hb value (± SD) at H0 was 10.9 ± 1.5 g/dL. Total mean estimated blood loss (± SD) was 877 ± 346 mL at the start of prostaglandin administration. Tranexamic acid was administered after inclusion to 48% of patients (median dose: 1g; range: 0.5-2g).